Clinical Research Assistant

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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For further inquiries regarding the following opportunity, please contact our Talent Specialists

Rakesh | 630 847 0275

Divya | 224 369 2969

Title: Clinical Research Assistant

Location: South Portland, ME

Duration: 12 Months

This role is a 100 percent on-site long-term position.

Description

• This position is NonExempt.
• Hours over 40 will be paid at Time and a Half.
• Entry-level position responsible for assisting the Clinical Research Associate in conducting Phase I - IV clinical studies according to ICH guidelines.
• The major role is to begin learning CRA work including verifying the content of critical regulatory documents, writing basic protocols, monitoring clinical sites, and reviewing case report forms (CRF's).
• 0-3 Years Experience Level.
• Candidates with clinical experience are a plus, but recent grads with some biological specimen experience and direct or indirect experience with finance/accounting (overall organized!) with a willingness to learn are a good fit as well.
• Experience working with biological specimens and data sets, ideally with some clinical trial familiarity Will be providing general administrative support to the Medical, Clinical, and Scientific Organizations and assistance to department Manager(s) and Director(s).
• The candidate will support the Clinical Operations teams with the ongoing conduct of studies.
• Needs to be familiar with ICH GCP, Good Documentation Practices, appropriate regulations, relevant SOP’s and internal tracking systems.
• Research or health care-related academic or work experience preferable High Attention to Detail and good computer skills Looking to start selected candidate ASAP after screenings clear.
  
  

Job Function/Responsibilities

• To provide general administrative support to the Medical, Clinical, and Scientific Organizations and assistance to department Manager(s) and Director(s).
• To assist the Clinical Operations teams in the completion of all required tasks to meet departmental and project goals.
• To support the Clinical Operations teams with ongoing conduct of studies.
• To be familiar with ICH GCP, Good Documentation Practices, appropriate regulations, relevant SOP’s and internal tracking systems.
• To assist in tracking of clinical studies and site-related purchase orders, invoice receipts, and facilitate the creation of new vendors in the purchasing system.
• To assist with the reconciliation of payments and resolve discrepancies, if applicable.
• To attend project team and department meetings and generate meeting minutes.
• To assist in the production of slides, overheads, etc., as needed for project, departmental, and/or site training presentations.
• To monitor and order study supply inventory.
• To create kits for collection of samples for clinical studies.
• Receive, log and store biological specimens.
• Create shipments and complete customs paperwork for packages to external collaborators.
• Enter data, run reports and perform QC of biological specimen database.
• Other duties as assigned
  
  

Qualifications/Experience Required

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skill, and/or ability required.

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Either relevant work experience or HS Diploma/Associate’s degree; Bachelor’s degree preferred(or equivalent).

Research or health care-related academic or work experience preferable.

Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.

Good written and verbal communication skills.

Good written and spoken English.

Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.

Willingness to travel for job-related activities if required (expected travel for this position is

About Us

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.